Treating glabellar lines with botulinum toxin type A-hemagglutinin complex: a review of the science, the clinical data, and patient satisfaction

Abstract

Botulinum toxin type A treatment is the foundation of minimally invasive aesthetic facial procedures. Clinicians and their patients recognize the important role, both negative and positive, that facial expression, particularly the glabellar frown lines, plays in self-perception, emotional well-being, and perception by others. This article provides up-to-date information on fundamental properties and mechanisms of action of the major approved formulations of botulinum toxin type A, summarizes recent changes in naming conventions (nonproprietary names) mandated by the United States Food and Drug Administration, and describes the reasons for these changes. The request for these changes provides recognition that formulations of botulinum toxins (eg, onabotulinumtoxinA and abobotulinumtoxinA) are not interchangeable and that dosing recommendations cannot be based on any one single conversion ratio. The extensive safety, tolerability, and efficacy data are summarized in detail, including the patient-reported outcomes that contribute to overall patient satisfaction and probability treatment continuation. Based on this in-depth review, the authors conclude that botulinum toxin type A treatment remains a cornerstone of facial aesthetic treatments, and clinicians must realize that techniques and dosing from one formulation cannot be applied to others, that each patient should undergo a full aesthetic evaluation, and that products and procedures must be selected in the context of individual needs and goals.

Keywords: botulinum toxin type A; cosmetic; glabellar; onabotulinumtoxinA; patient satisfaction.

Figure 1

Responder rates at each follow-up visit after treatment with onabotulinumtoxinA during the double-blind period of the study. A) Physician’s ratings of glabellar line severity at maximum frown. Responder rates were the percentage of subjects with ratings of none or mild. B) Subject’s assessment of changes in the appearance of glabellar lines. Responder rates were the percentages of subjects with a least moderate improvement.

Figure 2

Responder rates (percentage of subjects with ratings of none or mild) following each of 3 treatments with onabotulinumtoxinA: based on physician’s assessment of glabellar line severity at maximum frown (n = 258; subjects receiving all 3 treatments). Carruthers A, Carruthers J, Lowe NJ, et al; for the BOTOX^® Glabellar Lines I and II Study Groups. One-year, randomised, multicenter, two-period study of the safety and efficacy of repeated treatments with botulinum toxin type A in patients with glabellar lines. J Clin Res. 2004;7:1–20. © 2004 Informa Healthcare. Reproduced with permission. ^aIndicates that the value is significantly greater than the value at the same time point after one or both previous botulinum toxin treatments (P < 0.028). Arrow indicates time of botulinum toxin treatment.

Figure 3

Percentage of subjects with glabellar severity of none or mild post treatment. Investigator and subject assessments – Study GL-1; abobotulinumtoxinA, n = 105; placebo, n = 53.

Figure 4

Mean FLO scores after onabotulinumtoxinA or placebo treatment in subjects with moderate to severe glabellar lines. The double-blind phase of the study was 4 weeks in duration, but subjects were followed for 12 weeks. Reprinted with permission from Fagien S, Cox SE, Finn JC, Werschler WP, Kowalski JW. Patient-reported outcomes with botulinum toxin type A treatment of glabellar rhytids: a double-blind, randomized, placebo-controlled study. Dermatol Surg. 2007;33(1 Spec No):S2–S9. © John Wiley & Sons Inc; 2007. Abbreviation: FLD, Facial Lines Outcomes Questionnaire.

Figure 5

Patients’ reactions to treatment with onabotulinumtoxinA (N = 30). Reprinted with permission from Sommer B, Zschocke I, Bergfeld D, Sattler G, Augustin M. Satisfaction of patients after treatment with botulinum toxin for dynamic facial lines. Dermatol Surg. 2003;29(5):456–460. © John Wiley & Sons Inc, 2003.

Figure 6

Improvements in FLO scores in 2 studies following treatment with onabotulinumtoxinA. A) Reprinted with permission from Carruthers J, Carruthers A. Botulinum toxin type A treatment of multiple upper facial sites: patient-reported outcomes. Dermatol Surg. 2007;33(1 Spec No):S10–S17. © John Wiley & Sons Inc; 2007. B) Reprinted with permission from Fagien S, Cox SE, Finn JC, Werschler WP, Kowalski JW. Patient-reported outcomes with botulinum toxin type A treatment of glabellar rhytids: a double-blind, randomized, placebo-controlled study. Dermatol Surg. 2007;33(1 Spec No):S2–S9. © John Wiley & Sons Inc; 2007.